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Immune/Inflammatory Biomarkers in Postpartum Depression

NCT05784116 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-03-24

No results posted yet for this study

Summary

This will be a very straightforward study assessing changes of immune/inflammatory peripheral biomarkers before/after delivery with postpartum mood and the psychopathological features of postpartum depression (PPD), and with MRI measures of functional and structural brain integrity.

Multimodal assessment of peripheral cytokines, PBMC gene expression, FACS immunophenotyping, and IDO activation, will be validated with (a) clinical data about the presentation of PPD, (b) self- and observer ratings of psychopatology, (c) results coming from neuropsychological assessment of cognitive functions, and (d) multimodal brain imaging outcomes (WM integrity, functional connectivity, GM volumes).

It is expected that worsening or stabilization of mood, and the diagnosis of PPD, will be paralleled by worsening or stabilization of these measures, thus providing new markers to estimate the susceptibility to the disorder, to identify targets for treatment, and to predict and monitor treatment efficacy.

Conditions

  • Depression, Postpartum

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Francesco Benedetti, MD · IRCCS Ospedale San Raffaele, Milano

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2024-11-24
Completion
2024-11-24

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05784116 on ClinicalTrials.gov